MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, DOUBLE-DOUBLE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 3910-500-472

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: screw became loose in joint probable root cause: design: inadequate raw material selection for screw.Design geometry too sensitive to withstand clinical impaction loads.Screw/driver interface not designed to maintain proper assembly process.Screw or driver not manufactured to specification.Incorrect material used during manufacturing.Screw and driver not assembled to specification application.Excessive force or leveraging of the screw against the bone.Inadequate assessment of bone quality, pilot hole not prepared.

Event Description

It was reported that the screw become loose in the joint.

• Brand Name: OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, DOUBLE-DOUBLE
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 8495598
• MDR Text Key: 141339141
• Report Number: 0002936485-2019-00136
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 37613327464833
• UDI-Public: 37613327464833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3910-500-472
• Device Lot Number: 18353AG2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR